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Breast Cancer Screening: Digital Breast Tomosynthesis Versus Digital 2D Mammography

NCT ID: NCT03377036

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

99689 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-05

Study Completion Date

2026-03-31

Brief Summary

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This study is a randomized, multicenter, multivendor, controlled, diagnostic superiority trial to compare digital breast tomosynthesis plus synthesized 2D mammograms (DBT+s2D) versus standard 2D full-field digital mammography (2D-FFDM) regarding the effectiveness as screening modality.

Detailed Description

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The primary objective of the study is to evaluate whether digital breast tomosynthesis plus synthesized 2D mammograms leads to a relevant increase in the detection rate of screening-detected invasive cancers compared to 2D full-field digital mammography in routine screening according to the European Guidelines. Furthermore, the incidence rate of interval cancers within a 24 months interval after screening will be compared between both study arms in order to investigate the potential for overdiagnosis.

According to the pre-defined order of both primary endpoints and the primary objective of the study in the planning phase, the initial sample size calculation was based solely on the first primary endpoint (invasive breast cancer detection rate). Given the increasing national and international attention of interval cancers to assess the impact of potential overdiagnosis caused by tomosynthesis, we have planned a sample size increase from 80,000 to 120,000 study participants to achieve a reasonable statistical power for the evaluation of both primary endpoints. The revised sample size calculation was carried out without knowledge of the data from the currently recruiting TOSYMA study, i.e. all planning assumptions were based on external data that do not belong to the ongoing study.

Conditions

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Breast Cancer Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to either Digital Breast Tomosynthesis plus synthesized 2D mammograms (DBT+s2D) or 2D Full-Field Digital Mammography (2D-FFDM)
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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DBT+s2D

Digital breast tomosynthesis plus synthesized 2D mammograms

Group Type EXPERIMENTAL

DBT+s2D

Intervention Type DIAGNOSTIC_TEST

Digital breast tomosynthesis plus synthesized 2D mammograms

2D-FFDM

2D full-field digital mammography

Group Type ACTIVE_COMPARATOR

2D-FFDM

Intervention Type DIAGNOSTIC_TEST

2D full-field digital mammography

Interventions

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DBT+s2D

Digital breast tomosynthesis plus synthesized 2D mammograms

Intervention Type DIAGNOSTIC_TEST

2D-FFDM

2D full-field digital mammography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Women eligible to participate in the National Mammography Screening Program of Germany
* Informed decision for mammography screening
* Written informed consent
* No prior participation in the TOSYMA trial

Exclusion Criteria

* Breast cancer up to 5 years prior to study invitation
* Previous mammography examination \< 12 months,
* Breast implants
Minimum Eligible Age

50 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Walter Heindel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Clinic for Radiology, University of Muenster / University Hospital Muenster

Locations

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Screening-Einheit Hannover; Mammographie-Einheit Hannover

Hanover, Lower Saxony, Germany

Site Status

Screening-Einheit Niedersachsen Nordost; Mammographie-Einheit Lüneburg

Lüneburg, Lower Saxony, Germany

Site Status

Screening-Einheit Niedersachsen Nord; Mammographie-Einheit Stade

Stade, Lower Saxony, Germany

Site Status

Screening-Einheit Niedersachsen Mitte; Mammographie-Einheit Vechta

Vechta, Lower Saxony, Germany

Site Status

Screening-Einheit Niedersachsen Nordwest; Mammographie-Einheit Wilhelmshaven

Wilhelmshaven, Lower Saxony, Germany

Site Status

Screening-Einheit Aachen-Düren-Heinsberg; Mammographie-Einheit Aachen

Aachen, North Rhine-Westphalia, Germany

Site Status

Referenz-Screening-Einheit Münster-Nord/Warendorf; Mammographie-Einheit Ahlen

Ahlen, North Rhine-Westphalia, Germany

Site Status

Screening-Einheit Köln rechtsrheinisch, Leverkusen, Rhein.-Berg. Kreis, Oberbergischer Kreis; Mammographie-Einheit Bergisch Gladbach

Bergisch Gladbach, North Rhine-Westphalia, Germany

Site Status

Screening-Einheit Bielefeld, Gütersloh; Mammographie-Einheit Bielefeld

Bielefeld, North Rhine-Westphalia, Germany

Site Status

Screening-Einheit Münster-Süd; Mammographie-Einheit Coesfeld

Coesfeld, North Rhine-Westphalia, Germany

Site Status

Screening-Einheit Duisburg; Mammographie-Einheit Duisburg

Duisburg, North Rhine-Westphalia, Germany

Site Status

Screening-Einheit Gelsenkirchen, Kreis Recklinghausen, Bottrop; Mammographie-Einheit Gelsenkirchen

Gelsenkirchen, North Rhine-Westphalia, Germany

Site Status

Screening-Einheit Minden-Lübbecke, Herford; Mammographie-Einheit Herford

Herford, North Rhine-Westphalia, Germany

Site Status

Screening-Einheit Mönchengladbach, Krefeld, Viersen; Mammographie-Einheit Krefeld

Krefeld, North Rhine-Westphalia, Germany

Site Status

Screening-Einheit Höxter, Paderborn, Soest; Mammographie-Einheit Lippstadt

Lippstadt, North Rhine-Westphalia, Germany

Site Status

Referenz-Screeening-Einheit Münster-Nord/Warendorf; Mammographie-Einheit Münster-Nord

Münster, North Rhine-Westphalia, Germany

Site Status

Screening-Einheit Münster-Süd; Mammographie-Einheit Münster

Münster, North Rhine-Westphalia, Germany

Site Status

Screening-Einheit Höxter, Paderborn, Soest; Mammographie-Einheit Paderborn

Paderborn, North Rhine-Westphalia, Germany

Site Status

Screening-Einheit Märkischer Kreis, Hamm, Unna; Mammographie-Einheit Schwerte

Schwerte, North Rhine-Westphalia, Germany

Site Status

Screening-Einheit Raum Bergisch Land/Kreis Mettmann; Mammographie-Einheit Solingen-Mitte

Solingen, North Rhine-Westphalia, Germany

Site Status

Screening-Einheit Raum Bergisch Land/Kreis Mettmann; Mammographie-Einheit Wuppertal-Elberfeld

Wuppertal, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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Weigel S, Gerss J, Hense HW, Krischke M, Sommer A, Czwoydzinski J, Lenzen H, Kerschke L, Spieker K, Dickmaenken S, Baier S, Urban M, Hecht G, Heidinger O, Kieschke J, Heindel W. Digital breast tomosynthesis plus synthesised images versus standard full-field digital mammography in population-based screening (TOSYMA): protocol of a randomised controlled trial. BMJ Open. 2018 May 14;8(5):e020475. doi: 10.1136/bmjopen-2017-020475.

Reference Type BACKGROUND
PMID: 29764880 (View on PubMed)

Weigel S, Heindel W, Hense HW, Decker T, Gerss J, Kerschke L; TOSYMA Screening Trial Study Group. Breast Density and Breast Cancer Screening with Digital Breast Tomosynthesis: A TOSYMA Trial Subanalysis. Radiology. 2023 Feb;306(2):e221006. doi: 10.1148/radiol.221006. Epub 2022 Oct 4.

Reference Type DERIVED
PMID: 36194110 (View on PubMed)

Heindel W, Weigel S, Gerss J, Hense HW, Sommer A, Krischke M, Kerschke L; TOSYMA Screening Trial Study Group. Digital breast tomosynthesis plus synthesised mammography versus digital screening mammography for the detection of invasive breast cancer (TOSYMA): a multicentre, open-label, randomised, controlled, superiority trial. Lancet Oncol. 2022 May;23(5):601-611. doi: 10.1016/S1470-2045(22)00194-2. Epub 2022 Apr 12.

Reference Type DERIVED
PMID: 35427470 (View on PubMed)

Related Links

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http://bmjopen.bmj.com/content/8/5/e020475

BMJ Open

Other Identifiers

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HE1646/5-1 and HE1646/5-2

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UKM14_0016

Identifier Type: -

Identifier Source: org_study_id